NCT03178266: ZAPS

Zip Arthroplasty Patient Satisfaction Evaluation

Completed Results posted Last updated 15 May 2019

What this trial tests

trial testing Knee Arthroplasty in Knee Arthroplasty in 41 participants. Completed in 1 May 2018.

Timeline

1 December 2017

Primary endpoint
1 May 2018

1 May 2018

Quick facts

Lead sponsor	ZipLine Medical Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	41
Start date	1 December 2017
Primary completion	1 May 2018
Estimated completion	1 May 2018
Sites	1 location across United States

Drugs / interventions tested

• Knee Arthroplasty

Conditions studied

• Knee Arthroplasty — all drugs for Knee Arthroplasty →

Sponsor

ZipLine Medical Inc.

Who can join

Adults 18 to 80, any sex, with Knee Arthroplasty. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient and Observer Scar Assessment Scale (POSAS) Primary · 6 weeks post knee arthroplasty

The subject and investigator will rate commonly described scar characteristics from a patient and observers perspective Subject and Physician will rate overall opinion of scar to normal skin where 1-Normal to 10-Very Different

Subject Overall Opinion

Group	Value	95% CI
Zip Closure Device	2.25	± 1.52
Metal Staples	3.40	± 1.96

Surgeon Overall Opinion

Group	Value	95% CI
Zip Closure Device	1.10	± 0.31
Metal Staples	2.29	± 1.10

Patient Satisfaction Secondary · 6 weeks post knee arthroplasty

Subject Experience and Satisfaction results at 6 weeks post procedure. Subjects are asked of satisfaction with scar appearance on a scale of 1-minimal scar to 5-significant scar

Group	Value	95% CI
Zip Closure Device	1.45	± 0.76
Metal Staples	1.94	± 0.97

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Zip Closure Device

Serious: 0/21 (0%)

Deaths: 0/21

Metal Staples

Serious: 1/20 (5%)

Deaths: 1/20

Serious adverse events (1 terms)

Reaction	System	Zip Closure Device	Metal Staples
Death	Cardiac disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Zip Closure Device	Metal Staples
Blister lateral to distal end of closure	Skin and subcutaneous tissue disorders	—	—
Serous Drainage	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT03178266 adverse events section.

Sponsor's own description

This study is a prospective, randomized, single center, study to evaluate Zip Closure Device in subjects undergoing knee arthroplasty. Patients identified as candidates for knee arthroplasty and meet the study selection criteria will be approached and considered for the study. Knee Arthroplasty of 40 subjects will be enrolled where 20 subjects will receive ZipLine and 20 subjects will receive Staples.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Patient Satisfaction and Cosmetic Outcome in a Randomized, Prospective Study of Total Knee Arthroplasty Skin Closure Comparing Zip Surgical Skin Closure with Staples.
   Menkowitz B, Olivieri G, Belson O. · · 2020 · cited 9× · PMID 32117656 · DOI 10.7759/cureus.6705